Delta-Fly Pharma Inc.: Notice of initiation of patients enrollment in Phase III Pivotal comparative clinical trial of DFP-14323

We are excited to share our latest development status.

We are pleased to announce that the enrollment of patients in the Phase III clinical trial of DFP-14323 in combination with Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive that was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Feb. 2024, has started as of today in Japan.

This Phase III clinical trial will be conducted at 30 sites with NSCLC experts in Japan and the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint will be confirmed.

As DFP-14323 selectively binds to the aminopeptidase N, which is widely expressed on various cells, as lung cancer and inflammatory cells, it is expected to be effective in the treatment of patients with refractory cancer and when the superiority of the add-on effect can be confirmed in this study, it is expected to provide a novel cancer immunotherapy that is independent of EGFR mutation types, uncommon or common mutation.

We will accelerate the progress of the trial by expanding this Phase III clinical trial outside of Japan to Asian countries with large numbers of EGFR mutation-positive non-small cell lung cancer patients, and at the same time, we will promote out-licensing activities to Asian pharmaceutical companies.

Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO: 4598) and contact with us.